Actively Recruiting
A Clinical Study to Assess the Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy
Led by Tanta University · Updated on 2025-03-26
46
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cardiomyopathy is a serious condition marked by abnormalities in the heart muscle that lead to poor heart function and other health problems. Despite current treatments like ACE inhibitors and beta-blockers, many patients continue to face a poor outlook. Researchers are studying melatonin, a hormone known for regulating sleep and having antioxidant and anti-inflammatory effects, to see if it can protect the heart in patients with cardiomyopathy by targeting key disease processes such as oxidative stress and mitochondrial dysfunction. In this study, participants will receive 10 mg of melatonin once daily alongside their usual cardiomyopathy treatment for three months. The study includes a comparison group receiving a placebo. This randomized, double-blind trial aims to evaluate the heart-protective effects of melatonin by monitoring blood pressure, heart rate, echocardiographic heart function, and blood markers over the treatment period. Participants will undergo regular assessments including blood pressure and heart rate measurements, echocardiograms, and blood tests for markers like NT Pro-BNP at the start and throughout the three months of treatment. Researchers will track these measures to evaluate melatonin's impact on heart function and overall cardiovascular health. The study includes safety monitoring and follow-up throughout the treatment period, with total participation lasting about three months.
CONDITIONS
Brief Title
Cardioprotective Effects of Melatonin in Patients With Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients (≥18 years) with confirmed cardiomyopathy diagnosis by clinical, echocardiographic, or imaging findings
- Stable condition on standard cardiomyopathy medications (e.g., ACE inhibitors, beta-blockers)
- Ability to provide informed consent
You will not qualify if you...
- Recent hospitalization for cardiomyopathy worsening within the last 3 months
- Severe kidney or liver impairment
- Use of other investigational drugs or antioxidants
- Pregnancy or planning pregnancy in the next 6 months
- Known allergy to melatonin
- Presence of atrial fibrillation or significant arrhythmias at baseline
- Participation in another research study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive melatonin 10 mg once daily or standard cardiomyopathy therapy for 3 months.
Visits at baseline and periodically up to 3 months
Trial Site Locations
Total: 1 location
1
Mansoura University Hospital
Dakahlia, Egypt, Mansoura, Egypt, 35516
Actively Recruiting
Research Team
R
Reem Alaa, Bachelor of Pharmacy (2023)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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